BioCentury
ARTICLE | Clinical News

Sativex regulatory update

January 2, 2012 8:00 AM UTC

Sweden's Medical Products Agency approved GW Pharma's Sativex to treat moderate to severe spasticity due to multiple sclerosis (MS) in patients who have not responded adequately to other medications. Last year, Sativex was recommended for approval in 6 countries, including Sweden, under the EU Mutual Recognition Procedure (see BioCentury, March 28, 2011). GW said marketing partner Almirall S.A. (Madrid:ALM, Barcelona, Spain) expects to launch the product in Sweden in 1H12. In November, GW submitted regulatory applications for Sativex in about 10 European countries for the indication (see BioCentury, Dec. 5, 2011). ...